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Acorda TherapeuticsJ.P. Morgan Healthcare Conference January 16, 2020
J.P. MORGAN HEALTHCARE CONFERENCE 2020
Forward Looking Statement
This presentation includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market Inbrija or any other products under development; we may need to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and we may not be able to do so on acceptable terms or at all; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of Inbrija to meet market demand; third party payers (including governmental agencies) may not reimburse for the use of Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for Inbrija, Ampyra and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of Ampyra (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of Inbrija (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs ; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.
These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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Who We Are
• Acorda Therapeutics is a biotechnology company whose mission is to develop therapies that restore function and improve the lives of people with neurological disorders
• We have brought two commercial products to patients:
For the treatment of OFF episodes in people with Parkinson’s disease
For the improvement of walking in people with multiple sclerosis
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What is INBRIJA®?A Parkinson’s Disease therapy for
use as-needed to treat OFF periods
in patients on carbidopa/levodopa
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OFFPeriods during which (Parkinson’s)
symptoms re-emerge
ONPeriods during which (Parkinson’s)
symptoms are controlled
Patients Can Experience Varying Degrees of Symptoms Before or After Taking PD Medication
5Parkinson’s disease medications for medical professionals. Parkinson's Disease Clinic and Research Center, 2013. http://pdcenter.neurology.ucsf.edu/sites/pdcenter.neurology.ucsf.edu/files/Medications%20for%20PD_Professionals_2013%20APPROVED.pdf. Accessed September 11, 2017.
J.P. MORGAN HEALTHCARE CONFERENCE 2020
Based on the same survey, 50% experience OFF periods that lasted 45 minutes or longer
Two thirds of PD patients have 2+ hours of OFF time per day
45+ Minutes
Patients Have to Manage OFF Periods Every Day, Sometimes for Many Hours
Based on an online survey of more than 3,000 individuals with Parkinson's disease, 70% experienced at least 2 OFF periods per day
Almost half reported that OFF periods moderately to severely impacted their ability to perform activities Demographics (e.g., duration of disease, age, sex, medication history) were not collected in this survey.
2+ OFFs per Day
Reference: The Michael J. Fox Foundation Survey of Parkinson’s Patients’ Off Time Experience, July 2014.
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OFF Periods: A Significant Unmet Need Despite Many Oral Therapies Available Today
AGREEthe treatment of OFF periods is the greatest unmet need in PD
AGREEtherapies specifically designed to
treat OFF periods are needed
AGREEbeing OFF bothers them more than being ON with dyskinesia
AGREEmore than half of all OFF periods
are very bothersome
100%71% 81% 81%
Survey of PD PatientsSurvey of Physicians
Patients and physicians overwhelmingly agree there is an unmet need for therapies to treat OFF periods
Source:: Acorda quantitative market research.
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• INBRIJA is the only inhaled levodopa for as-needed treatment of OFF periods in patients on carbidopa/levodopa
• Onset of action: as early as 10 minutes post-dose
• Primary endpoint: significant improvement in motor function at 30 minutes post-dose (P=0.009)
• Continuation of effect: 60 minutes post-dose*
• The most common adverse reactions (≥5% and higher than placebo) were cough, upper respiratory tract infection, nausea and discolored sputum
* 60 minutes was longest time point assessed
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The INBRIJA Kit:• 60 sealed capsules• 1 inhaler• Prescribing Information
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INBRIJA : 2019 Progress and Key Learnings
Lessons Learned2019 Progress
Launch in February 2019 focused on physician awareness• ~ 75% unaided and ~ 92% aided awareness
• ~ 78% of physicians who are aware of INBRIJA® expect to increase prescribing
Reached agreement with several major payers• Majority of commercial lives now covered
• Medicare access improving
Prescribers are gating prescriptions• Reimbursement hurdles impact intent to prescribe
• Entrenched treatment algorithms
• Patient feedback cycle is long
Variable patient experience• Initial cough can be challenging
• Need to set appropriate expectations and train properly to optimize user experience
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Launch Phase 2
Activ
ities • Federal markets
• Long-term-care• Speaker programs• Patient ambassadors• Direct-to-patient initiatives• Educational programs
• Clinical presentations• Contract negotiations
• Speaker programs• Symposia and
conferences• In services• Direct-to-HCP
initiatives
Prio
ritie
s Physician Education
Managed Care Access
Expand Patient Base
Patient-Focused Marketing
Driving Commercial Success of INBRIJA in 2020:Phase 2 Focused on Driving Patient Awareness
Successful Phase 1 Launch
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Launch Phase 2: Executing on Significant Opportunity to Educate Patients on INBRIJA
INBRIJA
Physician Estimate of Patients Requesting & Receiving a Prescription for INBRIJA*
* Source: Acorda physician survey, August 2019. Survey consisted of 151 physicians, of which 111 physicians who use INBRIJA provided a response; n=111.
Drive demand by expanding patient awareness and education
Rx64% of Patients Requesting INBRIJA Received a Prescription
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Ampyra®
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Maintaining the Franchise Strength of AMPYRA
Loyalty to the brand is high
Continuing keysupport activities
Exploring other mechanisms to retain greater value
• Some patients have switched back to the brand from the generic
• “First Step” free trial program
• Physician and reimbursement support
• Maximizing cash flow
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2019 Review and 2020 Guidance
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Review of 2019 Positioning Acorda for Sustainable Value Creation
Commercial Launch of INBRIJA• Established high brand awareness among physicians
• Improved patient access: 72% commercial, 25% Medicare lives
• 2019 Net Product Revenue ~ $15 million
Maintaining AMPYRA• Strong revenue tail: 2019 net revenue of ~ $163 million
2019 Net Product Revenue*: ~ $178 millionTotal Revenue: ~ $188 million
Improving balance sheet and addressing cost structure• Executed convertible exchange to extend maturity
• Implemented corporate restructuring
Acorda’s long-term value proposition and 2020 outlook strengthened by 2019 actions* Unaudited revenue2019 product revenue excludes royalty revenue (primarily Fampyra royalty obligations owed to Healthcare Royalty Partners)
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Financial Guidance
Inbrija
2020 Inbrija sales: $35M – $40MInbrija Peak Sales: $300M – $500M
Ampyra2020 Ampyra sales: $85M – $110M
Acorda2020 Operating Expenses: $170M – $180M
Note: Operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation, as more fully described in our press release dated January 15, 2020 under “Non-GAAP Financial Measures”.
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INBRIJA Guidance Assumptions
Segmentation and Discontinuation Rates*
Segment % of Patients Discontinuation Rate(at 12 Months)
Contribution to Peak Sales
High Usage (3+ doses / day) 11 to 13% 20% 61%
Medium Usage (2 to 3 doses / day) 10 to 12% 35% 19%
Low Usage (1 to 2 doses / day) 14 to 16% 40% 14%
Trialing and Sporadic ~ 62% 95% 6%
Low End of Peak Sales Guidance Assume 2019 Observed Trends Remain Constant
* Discontinuation rates reflect data observed through year end 2019** Discontinuation is considered if a patient does not refill upon a specified number of days of last prescription fill
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Focused on Strengthening Capital Structure & Managing Operating Expenses
Focused on Aligning Cost Structure to Revenue while Prioritizing INBRIJA Launch
Managing cost structure• Headcount reduction of ~25%
– Operating expenses reduced by greater than $60 million
• Additional cost management:– Making cost structure more flexible
(fixed variable)
Successfully exchanged $276 million of 2021 convertible notes in Dec. 2019• Extended maturity to 2024
• Addressed 80% of near-term obligation
• Compelling ~ 95% conversion premium over market price
• Evaluating options to address $69 million of remaining convertible due in 2021
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Acorda’s Path Forward: 2020 Focus
Accelerate InbrijaCommercial Growth• Driving patient demand
• Expanding access
• Optimizing patient experience
Support AmpyraFranchise Strength• Maintaining brand loyalty
• Sustaining cash generation
• Maximizing profitability
Drive Long Term Value• Managing cost structure
• Strengthening balance sheet
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Acorda TherapeuticsJP Morgan Healthcare Conference January 16, 2020
J.P. MORGAN HEALTHCARE CONFERENCE 2020
Financial Results and Guidance Summary
2020 Product Guidance: $120 to 150 million2020 Total Revenue: $130 to $160 million
INBRIJA
2019 INBRIJA revenue*:• Q4 revenue $6.1 million• 2019 revenue $15.3 million
INBRIJA 2020 revenue:• $35 to $40 million
Peak sales expectations:• $300 to $500 million
AMPYRA
2019 AMPYRA revenue*:• Q4 revenue: $40.2 million• 2019 revenue: $162.6 million
AMPYRA 2020 revenue:• $85 to $110 million
Operating Expense
2019 year-end cash*• $169 million
2020 operating expense: • $170 to $180 million
Note: Operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation, as more fully described in our press release dated January 15, 2020 under “Non-GAAP Financial Measures”. Product guidance excludes royalty revenue (primarily Fampyra royalty obligations owed to Healthcare Royalty Partners)
*Unaudited
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